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New HTA Decisions in France
June 2020
Drug name
OPDIVO® - YERVOY® (nivolumab)
Company
Bristol-Myers Squibb
Decision date
10/07/2019
Therapeutic area
Cancer
Therapeutic sub area
Renal cancer
Official notice date
18/11/2019
Reimbursement %
Decision (SMR)
Important
Decision (ASMR)
Moderate improvement (III)
Indication
OPDIVO® - YERVOY® is indicated, in the first line, for the treatment of adult patients with advanced renal cell carcinoma of intermediate/adverse prognosis.
Decision Type
Extension of indication
Summary
The committee considered the actual benefit of OPDIVO® - YERVOY® to be 'important' only in the 1st line treatment of advanced clear cell renal cell carcinoma or renal cell carcinoma with clear cell component of intermediate/adverse prognosis. Considering: - the superiority of the nivolumab/ipilimumab combination compared with sunitinib, considered an acceptable comparator, in terms of overall survival (HR = 0.63, CI99.8% = [0.44, 0.89]; p <0.0024) in the only population of patients with clear cell renal cell carcinoma or renal cell carcinoma with clear cell component; - the increased toxicity of this combination compared to sunitinib with, in particular, a higher frequency of serious adverse events (55.8% vs 39.8%) or leading to discontinuation of treatment (30.7% vs 21.3%); - the partially covered medical need in this disease; - the pending results of the post-authorisation clinical study requested by the EMA to determine the contribution of ipilimumab to this combination; it was concluded that OPDIVO® - YERVOY® provides a moderate improvement in the medical service rendered (ASMR III) compared with sunitinib in the 1st line treatment of advanced clear cell renal cell carcinoma or renal cell carcinoma with clear cell component of intermediate/adverse prognosis.